Therapeutic Innovation & Regulatory Science

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Reasons for Premature Conclusion of Late Phase Clinical Trials: An Analysis of ClinicalTrials.gov Registered Phase III Trials
Therapeutic Innovation & Regulatory Science - Tập 54 - Trang 232-239 - 2020
Daphne Guinn, Erin E. Wilhelm, Ira Shoulson
Confirmatory phase III trials aim to provide decisive evidence about a medical product’s safety and efficacy. Although these trials are planned and conducted based on accumulated knowledge, they are not without risk or uncertainty. A trial prematurely concluding contributes to great loss in both financial and human research resources. We categorized and evaluated trials concluded prematurely after... hiện toàn bộ
Patient Comprehension of Medication Guides for Asthma and Chronic Obstructive Pulmonary Disease Medications
Therapeutic Innovation & Regulatory Science - - 2014
Rachael L. DiSantostefano, Melissa J. Beck, Anne Yeakey, Ibrahim Raphiou, David A. Stempel
Quality of Medicine Information in Product Information Leaflets: A Retrospective Audit
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 656-660 - 2018
M. S. S. Saheeha, M. H. S. Piumanthi, S. P. Perera, N. R. Samaranayake, G. H. Fernando
Nonstandard product information leaflets (PIs) may lead to medication errors. We assessed the completeness, and compatibility of, essential information against reference sources in selected PIs of medicines used in Sri Lanka. Hundred PIs each were used to assess completeness and compatibility of information, respectively. Availability of essential information was checked against drug regulations o... hiện toàn bộ
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
Therapeutic Innovation & Regulatory Science - Tập 56 - Trang 753-764 - 2022
Jenn W. Sellers, Camelia M. Mihaescu, Kassa Ayalew, Phillip D. Kronstein, Bei Yu, Yang-Min Ning, Miguel Rodriguez, LaKisha Williams, Ni A. Khin
The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported. We identified common inspections of clinical investigators, sponsors, an... hiện toàn bộ
Extrapolation of Efficacy in Pediatric Drug Development and Evidence-based Medicine: Progress and Lessons Learned
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 199-205 - 2018
Haihao Sun, Jean W. Temeck, Wiley Chambers, Ginger Perkins, Renan Bonnel, Dianne Murphy
“Complete Extrapolation” of efficacy from adult or other pediatric data, to the pediatric population, is an important scientific tool that reduces the need for pediatric efficacy trials. Dose finding and safety studies in pediatrics are still needed. “No Extrapolation” requires 2 pediatric efficacy trials. “Partial Extrapolation” eliminates the need to conduct 2 pediatric efficacy trials; 1 effica... hiện toàn bộ
Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia
Therapeutic Innovation & Regulatory Science - Tập 56 - Trang 523-529 - 2022
Atsushi Noguchi, Hideki Hanaoka, Yoshiaki Uyama
Although the “drug lag”—namely, the delay in drug approval time in Japan relative to the United States and/or European Union (US/EU)—has been shortened for drugs approved in Japan, there remain many new drugs that have been approved in the US/EU, but not in Japan. To assess the possibility of a future drug lag, this study has examined the current lag in drug development in Japan based on “Clinical... hiện toàn bộ
Improving Good Practice: A Survey of Unlicensed and Off-Label Drug Use in a General Hospital in China
Therapeutic Innovation & Regulatory Science - Tập 47 - Trang 397-404 - 2013
Hanbin Wu, Gao Wu
Off-label and unlicensed drug use is common in Europe and the US; however, information about this issue in China is limited. To determine the scope and scale of off-label and unlicensed drug use in general hospitals in Shanghai, China, and to evaluate the varying levels of supporting evidence. A total of 493 cases of discharge history were randomly sampled. Off-label uses were defined according to... hiện toàn bộ
New Benchmarks Characterizing Growth in Protocol Design Complexity
Therapeutic Innovation & Regulatory Science - Tập 52 - Trang 22-28 - 2018
Kenneth A. Getz, Rafael A. Campo
The Tufts Center for the Study of Drug Development and Medidata Solutions Inc analyzed data from 9737 protocols and 130,601 investigative site contracts associated with these protocols to derive updated benchmarks characterizing protocol complexity. The results of the study indicate that protocol design complexity continues to grow rapidly. Nearly all phase I, II, and III complexity measures assoc... hiện toàn bộ
Costs of Quality in Clinical Development
Therapeutic Innovation & Regulatory Science - Tập 53 - Trang 706-713 - 2019
Bolennart Eriksson
The basis for this article is an individual project during a Master of Science program at Cranfield University, UK. Research and development (R&D) costs in the pharmaceutical industry have increased at a rate where costs have doubled compared to previous decades since the 1980s. In parallel, during recent years, there has been an increased focus on quality management within clinical development. F... hiện toàn bộ
An Improved Matching Practice for Augmenting a Randomized Clinical Trial with External Control
Therapeutic Innovation & Regulatory Science - Tập 57 - Trang 611-618 - 2023
Jianghao Li, Yu Du, Huayu Liu, Yanyao Yi
The use of information from real world to assess the effectiveness of medical products is becoming increasingly popular and more acceptable by regulatory agencies. According to a strategic real-world evidence framework published by U.S. Food and Drug Administration, a hybrid randomized controlled trial that augments internal control arm with real-world data is a pragmatic approach worth more atten... hiện toàn bộ
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